Stavanger University Hospital
Stavanger, Rogaland, 4068, Norway
NCT Number: NCT05659823
To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.
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Notify Me18 year–60 year
Female
Interventional
Phase 4
Stavanger, Rogaland, 4068, Norway
Control group (current analgesia, elective CS) is compared to current analgesia for emergency CS, and guideline recommended analgesia.
Current analgesia for CS:
Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 10-15 ug. Postoperative: Paracetamol 1g x 4, ibuprofen 400 mg x 4 po, oxycodone 10 mg (<70 kg) or 20 mg (>70 kg) x 2 po, additional oxycodone 2,5 mg iv/5 mg po when needed.
Guideline recommended analgesia for CS:
Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 12,5 ug. Spinal morphine 0,05 mg. After delivery of baby: Dexamethasone 8 mg iv, paracetamol 1g iv, parecoxib 40 mg iv.
Postoperative: Paracetamol 1g x 4, ibuprofen 600 mg x 4 po, oxycodone 2,5 mg iv/5 mg po when needed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guideline recommended analgesia in elective caesarian section.
Current analgesia in elective caesarian section.
Current analgesia in emergency caesarian section.
Time frame: Immediately upon arrival at postoperative care unit
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At postoperative care unit 30 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At postoperative care unit 60 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At postoperative care unit 90 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At postoperative care unit 120 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: Immediately upon arrival at maternity ward
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At maternity ward 4 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At maternity ward 8 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At maternity ward 12 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At maternity ward 16 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: At maternity ward 20 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time frame: During stay at postoperative care unit, estimated average 2 hours
Present (yes/no) during stay at the postoperative care unit
Time frame: During stay at maternity ward, estimated average 22 hours
Present (yes/no) during stay at the maternity ward
Time frame: During stay at postoperative care unit, estimated average 2 hours
Present (yes/no) during stay at the postoperative care unit
Time frame: During stay at maternity ward, estimated average 22 hours
Present (yes/no) during stay at the maternity ward
Time frame: During stay at postoperative care unit, estimated average 2 hours
Number of mg of oxycodone administered as additional analgetics
Time frame: During stay at maternity ward, estimated average 22 hours
Number of mg of oxycodone administered as additional analgetics
Conrad Arnfinn Bjørshol
Other Gov
Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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